Risperidone

Product NDC: 70518-4426
Requested package NDC: 70518-4426-0
11-digit product format: 705184426
Labeler code: 70518
Product ID: 70518-4426_3bb76a8d-e1db-b885-e063-6294a90a0395
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risperidone
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077493
Marketing category: ANDA
Marketing start: 2025-08-06
Substance: RISPERIDONE
Active strength: 3 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077493-001	RISPERIDONE	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29
A077493-002	RISPERIDONE	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29
A077493-003	RISPERIDONE	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29
A077493-004	RISPERIDONE	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29
A077493-005	RISPERIDONE	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29
A077493-006	RISPERIDONE	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A077493-001	AB
A077493-002	AB
A077493-003	AB
A077493-004	AB
A077493-005	AB
A077493-006	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-005	RISPERIDONE	3MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-006	RISPERIDONE	4MG	TABLET / ORAL	AB	2011-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-001	RISPERIDONE	0.25MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-002	RISPERIDONE	0.5MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-003	RISPERIDONE	1MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-004	RISPERIDONE	2MG	TABLET / ORAL	AB	2011-11-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077493-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077493-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077493-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077493-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077493-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077493-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077493-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077493-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077493-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Risperidone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISPERIDONE	3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L6UH7ZF8HC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312832	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
339ec0af-c0f0-4115-8cdb-8f052e633f47	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6	Product name	5	20250303
0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e	Product name	1	20250128
e457a910-2c3a-4bfd-90b9-0310982c50dd	Product name	1	20241218
42b1a2d5-888a-4386-ab9f-0979e0d7b4aa	Product name	1	20231010
66685e90-862d-4873-a0c5-2be73b803c36	Product name	1	20230921
92d220a1-2a4c-4393-9080-7335ca8223cc	Product name	1	20230823
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-4426-0	Risperidone	30 in 1 BLISTER PACK	TABLET	30		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Coupler LLC	55f3ebec-a742-48fc-e063-6394a90a1452	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	c84807bd-35d7-4138-8989-42617d69293a	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Solco Healthcare US, LLC	43aa2a4f-1123-4f86-800b-9218882f7bcd	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	3261e8cf-cc6e-4011-9246-aee623ad8971	2025-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	REMEDYREPACK INC.	339ec0af-c0f0-4115-8cdb-8f052e633f47	2025-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493 ndc (package): 70518-4426-0 ndc (product): 70518-4426 ndc11 (package): 70518442600
Risperidone	RISPERIDONE	NuCare Pharmaceuticals, Inc.	390904c2-fcfa-466e-e063-6394a90a03af	2025-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Bryant Ranch Prepack	684dcda4-d270-400c-9798-7d920a038bbb	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	7bbc37f1-6d6a-4021-8976-1f103ce1cfbd	2023-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493
Risperidone	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	58e422ec-da66-41b0-83c1-aefd940beda0	2019-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077493 application number: ANDA077493

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6UH7ZF8HC	RISPERIDONE	106266-06-2	RISPERIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312832	risperiDONE 3 MG Oral Tablet	PSN	339ec0af-c0f0-4115-8cdb-8f052e633f47	1
312832	risperidone 3 MG Oral Tablet	SCD	339ec0af-c0f0-4115-8cdb-8f052e633f47	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4426-0	70518442600	30 TABLET in 1 BLISTER PACK (70518-4426-0)	30 tablet	2025-08-06	No	No	Current